B. Braun TSPACE 3D User manual

1

SPINE SURGERY

AESCULAP® TSPACE® 3D

SURGICAL MANUAL

TRANSFORAMINAL INTERBODY FUSION SYSTEM

2

AESCULAP® LUMBAR SPINE

RELIABLE PARTNER IN SPINE SURGERY

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portfolio by clicking on this area.

www.bbraun.com/spine-surgery

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Modern lifestyle has resulted in increasing physical inactivity among people all over the world. Of the many

medical problems associated with this, spinal disorders are among the most critical. This is even more

signicant as the spinal column is one of the most important structures in the human body.

It supports and stabilizes the upper body and is the center of our musculoskeletal system, which gives the

body movement. Our work in the eld of spine surgery is dedicated to protecting the spinal column and

preserving its stability. We support spine surgeons with durable, reliable products and partner services for

reliable procedures and good clinical outcomes (1-7).

Our philosophy of sharing expertise with healthcare professionals and patients allows us to develop

innovative implant and instrument systems that help to preserve stability and stabilize the cervical and

thoracolumbar spine.

PROTECTING AND PRESERVING

SPINAL STABILITY

AESCULAP® TSPACE® 3D

CONTENT

A IMPLANT MATERIAL 4

B INTENDED USE & IMPLANT DESIGN 7

CSURGICAL TECHNIQUE 8

C.01. PATIENT POSITIONING 8

C.02. EXPOSURE OF THE INTERVERTEBRAL SPACE 8

C.03. RESTORATION OF DISC HEIGHT 9

C.04. DISCECTOMY 9

C.05. PREPARATION OF ENDPLATES 10

C.06. IMPLANT SELECTION 10

C.07. IMPLANT REMOVAL FROM PACKAGING 11

C.08. FILLING OF CAGE 11

C.09. TSPACE® 3D INSERTION 12

C.10. TSPACE® 3D FINAL IMPLANT POSITIONING 13

C.11. POSTERIOR STABILIZATION 15

C.12. ASSEMBLING OF THE TSPACE® INSERTER SN705R 16

DIMPLANT OVERVIEW 20

E INSTRUMENT OVERVIEW 22

4

AESCULAP® TSPACE® 3D

A. IMPLANT MATERIAL

THE TECHNOLOGY OF LASER SINTERING –

A WELL-ESTABLISHED ADDITIVE LAYER

BY LAYER PROCESS

❙Additive manufacturing – 3D printing –

means a layer by layer process to design

a device using laser beam and metal

powder. This innovative laser beam melt-

ing technology is of growing importance

in the manufacture of implants, as it

allows to create various ne and porous

surface structures with the aim to sup-

port bone-ingrowth. Homogenous or

heterogeneous lattice structures or com-

binations of various kinds of structures

and surfaces are generally conceivable.

 ›Direct assembly of the component

based on 3D-CAD data

 ›Design freedom

We combined our long-time experience

in designing and manufacturing spinal

implants with latest technology and pro-

duce in-house our AESCULAP® 3D Cages

(Fig. 1).

1.

Laser beam melting technology

5

A

B

C D

E

F

G

AESCULAP® 3D Cages are engineered from

Structan® – a lattice structure with largely

isotropic behavior. Ti6Al4V ELI was chosen

as a proven and biocompatible material

for implants (8).

MORE CONNECTION

❙The lattice structure of the AESCULAP® 3D

Cages shows an interconnected pore

structure (Fig. 2 / 3). This interconnectivity

facilitates migration of bone cells into the

structure, thereby providing secondary

stability (9, 10).

❙According to the average pore size and

porosity of cancellous bone (approxi-

mately 1 mm / 50 - 90 % (11)) the 3D

lattice structure Structan® features an

all-over regular pore size of 900 μm as

well as a mean interconnected porosity

of 50 - 55 %. Pore size and porosity are

in a favorable range to stimulate bone

in-growth (12, 13).

❙The results of a sheep study with partly

loaded implants conrm bone growth on

and into the 3D lattice structure without

connective tissue layer six months post-

operatively. This formation of bone tissue

within the 3D lattice structure leads to a

high secondary stability (10). The 3D lat-

tice structure serves as a guide rail for

bony integration and thus contributes

signicantly to the secure anchoring of

the 3D Cage (Fig. 4).

❙A rough laser sintered surface provides a

good interaction between bone cells and

implant surface compared to a milled

smooth surface and therefore intends to

optimize osseointegration (14).

2. 3.

4.

Lattice structure Structan®

Histological section of the 3D Cage lattice structure lled with newly formed bone

Unit cell with tted ball of 900 μm

Ti Bone

6

MORE ELASTICITY

❙ Ti6Al4V ELI as solid material has a Young’s

modulus of approximately 110GPa as it is

shown in the gure, whereas cortical

bone has a Young’s modulus of approxi-

mately 5 GPa (15, 16). The Young’s

modulus of Structan® is developed to be

close to that of cortical bone (17). This

may prevent subsidence into the vertebral

body (18). In addition, this may result

in improved bone growth (19) (Fig. 1).

MORE STRENGTH

❙The 3D lattice structure Structan® com-

bines a bone-like Young’s modulus with

a high compressive strength, which con-

tributes to high safety against failure

due to breakage.

The compressive strength of the 3D

lattice structure Structan® is higher than

the mean strength of bone and PEEK

(20-22) (Fig. 2).

AESCULAP® TSPACE® 3D

A. IMPLANT MATERIAL

1.

2.

nCancellous Bone (15)

nPEEK (21)

nCortical Bone (15)

nCancellous Bone (20)

nCortical Bone (20)

n3D lattice structure Structan® (17)

nTitanium 6AL4V (16)

nPEEK (21)

n3D lattice structure Structan® (22)

MATERIAL

YOUNG´S

MODULUS

(GPA)

80

100

60

20

40

0

COMPRESSIVE

STRENGTH

(MPa)

175

125

150

100

75

25

50

0

Young´s modulus of various materials

Compressive strength of 3D lattice structure Structan®

4.0

3.8

12.3

4.9

110

8

156

155

199

7

❙Stabilization of the lumbar and thoracic

spine through transforaminal approach,

monosegmental and multisegmental.

❙Always use TSPACE® 3D in conjunction

with an internal xator.

❙TSPACE® 3D can be implanted through

an open or minimally invasive trans-

foraminal access.

❙Solid frame without sharp edges for

biomechanical stability and smooth in-

sertion into the disc space minimizing

the risk to injure surrounding soft tissue.

❙Open porous structure designed to pro-

vide primary and secondary stability.

❙The implant’s anatomical endplate

design provides a good contact area

between implant and vertebral end-

plates whilst allowing addition of

bone material to enable bone growth

through the center of the implant.

❙Bulleted nose for smooth insertion into

the disc space.

❙The articulating interface allows a rm

connection to the inserter until the

nal implant positioning is achieved,

thus enabling a controlled insertion.

❙Good visibility in X-ray to localize implant

positioning (23, 24).

3.

B. INTENDED USE & IMPLANT DESIGN

A

B

C D

E

F

G

8

C.01. PATIENT POSITIONING

❙The patient is positioned in the prone

position for transforaminal interbody

fusion with supplemental  xation (Fig. 1).

❙The TLIF technique describes the unilateral

insertion of a single implant through a

transforaminal approach.

❙TSPACE® 3D can be implanted through

an open or minimally invasive access.

1.

C.02. EXPOSURE OF THE INTERVERTEBRAL

SPACE

❙Using an osteotome and a Kerrison bone

punch the bone resection is performed

to get access to the disc space. For a

transforaminal approach to the disc the

facet joint is resected on the side target-

ed for the implant insertion. The inferior

articular process of the facet joint is re-

sected  rst, then the subjacent superior

articular process is resected (Fig. 2 / 3).

❙In order to make room for the insertion of

the distractor, resection of disc material is

carried out using rongeurs and forceps.

2. 3.

AESCULAP® TSPACE® 3D

C. SURGICAL TECHNIQUE

9

C.03. RESTORATION OF DISC HEIGHT

❙The desired distraction can be set using

the distractors, available in heights from

7 - 15 mm in 1 mm increments.

❙Starting with the smallest height, the

distractor must be inserted horizontally

and then rotated clockwise (Fig. 4).

❙Rotate clockwise for a blunt height

restoration maneuver. Rotate counter-

clockwise to remove disc material with

the built-in sharp rim.

❙The distractors are inserted one after

the other until the desired distraction

is obtained.

4.

C.04. DISCECTOMY

❙The disc space is cleared using various

rongeurs and curettes. The right- and

left-angled curettes facilitate removal of

cartilaginous material in the far lateral

disc space (Fig. 5 / 6 / 7).

5.

6.

7.

A B

C

D

E

F

G

10

C.05. PREPARATION OF ENDPLATES

❙The bone rasps are used to refresh the

cartilaginous endplates (Fig. 1).

C.06. IMPLANT SELECTION

❙Use the inserter to insert the trial

implant until the  nal end position.

❙The trial positioning is done in the

same way as the implant positioning,

please refer to C.09 / C.10. (Fig. 2 / 3).

❙Start with the smallest trial size. Step-

wise the next heights are inserted until

the required distraction is achieved.

❙Use X-ray control to verify trial implant

positioning.

1.

2.

INFORMATION

Make certain that the endplates of the

neighboring vertebral bodies are not

weakened, in order to minimize the risk

of migration.

Make certain that the implant bed is

properly prepared to avoid damage to

the implant when it is driven in.

INFORMATION

Please refer to C.12. for a detailed assem-

bling description of the articulating inserter.

INFORMATION

It is essential to use trial implants to

establish the correct implant size.

AESCULAP®TSPACE® 3D

C. SURGICAL TECHNIQUE

3.

11

❙Connect the slap hammer to the handle

of the inserter (Fig. 4).

❙Use the slap hammer to back out the

trial carefully.

C.07. IMPLANT REMOVAL FROM PACKAGING

❙Open folder blister to remove the

TSPACE® 3D implant.

❙The packaging concept allows implant

removal with the connected inserter.

C.08. FILLING OF CAGE

❙Use the packing block and the punch for

optional  lling of the implant with bone

or bone substitute (Fig. 5).

3.

5.

INFORMATION

The trials are essential to ensure the

correct implant size to be used.

INFORMATION

Do not use force during  lling to avoid

implant damaging.

4.

A B

C

D

E

F

G

12

C.09. TSPACE® 3D INSERTION

❙It is recommended to place bone graft

in the anterior part.

❙Mount the TSPACE® 3D implant along

the axis of the instrument (Fig. 1).

❙Ensure that the tip of the insertion rod

is in horizontal position to connect the

implant with the inserter. At this point,

the marking shows plug lock open and

rotation stop at 90° (Fig. 2).

❙Turn the big rotary wheel next to the

handle until the marking shows plug

lock is closed. Now the implant is  rmly

hold (Fig. 3 / 4).

❙Bring rotation stop to 0° position to block

the rotation during initial insertion (Fig. 4).

❙Recheck the connection between the

implant (and respectively trial implant

C.06.) and the inserter.

1.

3.

AESCULAP®TSPACE® 3D

C. SURGICAL TECHNIQUE

4.

2.

13

❙The TSPACE® 3D implant is introduced

straight into the intervertebral space by

gentle hammering on the intended sur-

face of the handle (Fig. 5).

❙Use the nerve root retractors to protect

the dura during insertion.

C.10. TSPACE® 3D FINAL IMPLANT

POSITIONING

❙Slightly turn the big rotary wheel counter

clockwise to release the preload. There-

fore turn the big rotary knob just one

thumb movement in counterclockwise

direction, i. e. approx. up to the frame.

❙Pulling back the stop rod to 90° by

turning the union nut allows a rotation

maneuver of the implant.

❙Carefully hammer in the implant until it

reaches the  nal position required. When

hammering in to further advance the cage

into the disc space ensure that the big

rotary knob is still suﬃ ciently tightened.

❙Alternatively, stepwise pull out the stop

rod by turning the union nut (rotation

range is between 0° and 90°) and further

hit the implant with the mallet until it

reaches the stop. Repeat until the  nal

position is reached. If rotation maneuver

is done stepwise, recheck the tension of

the big rotary wheel. (Fig. 6 / 7).

3.

6.

5.

A B

C

D

E

F

G

7.

14

❙Intra-operative X-ray control to verify

the implant positioning (Fig. 1).

❙After the  nal positioning release the

implant and remove the inserter by turn-

ing the big rotary wheel until the mark-

ing shows plug lock is open (Fig. 2).

❙It is recommended to put bone material

harvested from the facet joint around the

TSPACE® 3D implant.

INFORMATION

Carefully pull the inserter out of the

implant. Avoid tilting of the instrument.

INFORMATION

Ensure not to turn further than “plug lock

open” and that the black bar marking is

still visible in the shaft window.

AESCULAP®TSPACE® 3D

C. SURGICAL TECHNIQUE

1. 2.

15

C.11. POSTERIOR STABILIZATION

❙Additional posterior stabilization of

the motion segment using AESCULAP®

Ennovate® Open Module (surgical

technique O48102) or AESCULAP®

Ennovate® MIS Module (surgical tech-

nique O00702) should be performed

(Fig. 3).

❙Subsequent segmental compression

with posterior instrumentation allows

loading of the anterior column and

restoration of sagittal alignment.

❙Final X-ray.

A B

C

D

E

F

G

3.

16

C.12. ASSEMBLING OF THE TSPACE®

INSERTER SN705R

❙The inserter consists of three parts and

the handle (Fig. 1).

1 Shaft

1a Rotary wheel

2 Bayonet rod

3 Rotation stop with stop rod

3a Union nut

❙To assemble the inserter  rst put the

bayonet rod 2 in the shaft 1 up to the

stop. Markings on the shaft and the

bayonet rod (line to line) have to be ob-

served (Fig. 2).

AESCULAP®TSPACE® 3D

C. SURGICAL TECHNIQUE

1.

2.

BLACK BAR MARKING

LINE TO LINE MARKING

1a

3a

1

2

3

INFORMATION

Please consider regular oiling.

17

❙After the stop is achieved (Fig. 3) turn

bayonet rod 90° and push it further in

shaft 1.

❙Turn rotary wheel 1a in clockwise direc-

tion until the black bar marking of the

bayonet rod 2 is visible in the window

(Fig. 4).

A B

C

D

E

F

G

3.

4.

18

❙Put the rotation stop 3 in the lateral slot

of shaft 1 and push it until the threads

(Fig. 1).

❙Turn the union nut 3a in counterclock-

wise direction up to the stop (Fig. 2).

AESCULAP®TSPACE® 3D

C. SURGICAL TECHNIQUE

1.

2.

LATERAL SLOT

19

❙Attach handle SO505R to the inserter

(Fig. 3 / 4).

❙The handle oﬀ ers the possibility to attach

the slap hammer extension SN320R for

trial removal.

A B

C

D

E

F

G

3.

4.

20

Article No. Size (Height x Width x Length) Quantity

SN707T 7 x 11.5 x 26 mm 2

SN708T 8 x 11.5 x 26 mm 2

SN709T 9 x 11.5 x 26 mm 2

SN710T 10 x 11.5 x 26 mm 2

SN711T 11 x 11.5 x 26 mm 2

SN712T 12 x 11.5 x 26 mm 2

SN713T 13 x 11.5 x 26 mm 2

SN715T 15 x 11.5 x 26 mm 2

SN727T 7 x 11.5 x 30 mm 2

SN728T 8 x 11.5 x 30 mm 2

SN729T 9 x 11.5 x 30 mm 2

SN730T 10 x 11.5 x 30 mm 2

SN731T 11 x 11.5 x 30 mm 2

SN732T 12 x 11.5 x 30 mm 2

SN733T 13 x 11.5 x 30 mm 2

SN735T 15 x 11.5 x 30 mm 2

AESCULAP®TSPACE®3D

D. IMPLANT OVERVIEW

Length

Width

Nominal height

LORDOSIS 5°

Angle

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B. Braun TSPACE 3D User manual

B. Braun TSPACE 3D User manual

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